Cleared Traditional

K881403 - MCCAIN MONOPOLAR & BIPOLAR CAUTERY

K881403 is an FDA 510(k) clearance for MCCAIN MONOPOLAR & BIPOLAR CAUTERY, manufactured by Walter Lorenz Surgical, Inc.. The device is a Class 2 General & Plastic Surgery device with product code GEI cleared through the Traditional 510(k) pathway after a 79-day FDA review.

K881403 · Walter Lorenz Surgical, Inc. · General & Plastic Surgery device
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Jun 1988
Decision
79d
Days
Class 2
Risk

K881403 is an FDA 510(k) clearance for the MCCAIN MONOPOLAR & BIPOLAR CAUTERY. Classified as Electrosurgical, Cutting & Coagulation & Accessories within the GEI classification (a category for electrosurgical cutting and coagulation devices), Class II - Special Controls.

Submitted by Walter Lorenz Surgical, Inc. (Jacksonville, US). The FDA issued a Cleared decision on June 22, 1988 after a review of 79 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4400 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Walter Lorenz Surgical, Inc. devices

FDA 510(k) Submission Details - K881403

510(k) Number K881403 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 04, 1988
Decision Date June 22, 1988
Days to Decision 79 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
36d faster than avg
Panel avg: 115d · This submission: 79d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GEI Device Classification - Class 2, Special Controls

Product Code GEI Electrosurgical, Cutting & Coagulation & Accessories
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4400
Definition Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission If The Device Is Reusable And Has Specific Design Features (please Refer To Table 2 Of 82 Fr 26807, Available At Https://www.gpo.gov/fdsys/pkg/fr-2017-06-09/pdf/2017-12007.pdf).
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most General & Plastic Surgery devices follow this clearance model.

Regulatory Peers - GEI Electrosurgical, Cutting & Coagulation & Accessories

All 1749
Devices cleared under the same product code (GEI) and FDA review panel - the closest regulatory comparables to K881403.
YESNG SUPER FRECATOR
K882903 · Ferguson Medical · Jul 1988
LECTROBRASIVE(R) E2401
K882646 · Valleylab, Inc. · Jul 1988
FIBER OPTIC LIGHT SOURCE CAT. #E9100
K882742 · Valleylab, Inc. · Jul 1988
SMOKEVAC ELECTORSURGICAL PENCIL
K881460 · Byron Medical · May 1988
BIPOLAR MICRO COAGULATOR MODELS 25-1000 & 25-1200
K880863 · New England Surgical Instrument Corp. · Apr 1988
YESNG REUSABLE ELECTROSURGICAL ELECTRODE
K881406 · Ferguson Medical · Apr 1988